Assessment Status | NCPE Assessment Process Complete |
HTA ID | 22024 |
Drug | Enfortumab vedotin |
Brand | Padcev® |
Indication | As monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor |
Assessment Process | |
Rapid review commissioned | 22/04/2022 |
Rapid review completed | 18/05/2022 |
Rapid review outcome | A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of enfortumab vedotin (Padcev®) compared with the current standard of care. |
Full pharmacoeconomic assessment commissioned by HSE | 27/05/2022 |
Pre-submission consultation with Applicant | 19/07/2022 |
Full submission received from Applicant | 23/11/2022 |
Preliminary review sent to Applicant | 16/03/2023 |
NCPE assessment re-commenced | 17/04/2023 |
Factual accuracy sent to Applicant | 21/06/2023 |
NCPE assessment re-commenced | 28/06/2023 |
NCPE assessment completed | 12/07/2023 |
NCPE assessment outcome | The NCPE recommends that enfortumab vedotin (Padcev®) not be considered for reimbursement unless cost-effectiveness can be improved relative to existing treatments*. |
*This recommendation should be considered while also having regard to the criteria specified in the Health (Pricing and Supply of Medical Goods) Act 2013.